Labeler · US market

EDW PHARMA, INC

EDW PHARMA, INC is a US drug labeler with US FDA registrations covering 1 drug concept (1 currently active) across 4 packages. It is currently the only active US supplier of 1 drug. The company files with FDA under 2 name variants, merged into this profile.

Also files as: EDW PHARMA

ACTIVE — US

openFDA · updated weekly

Labeler codes70726

Active drugs1

Registrations4 active / 4

Packages4

Sole supplier of1 drugs

Portfolio1 drugs · US

Every drug concept this labeler has US registrations for, by package count.

Drug	Type	NDCs	Packages	Status
Riluzole liquid	rx	4	4	SUPPLYING

Sole US supplier

Drugs where this labeler is currently the only active US supplier — a single point of failure if it exits.

Riluzolerx

At a glance

TypeLabeler
Labeler codes70726
Filing names2
Drugs (active)1
Drugs (all time)1
US registrations4
Packages4

Recent events

Shortages, recalls, and registration changes across all filing names.

Jan 26, 2024
SHORTAGEDrug shortage: Riluzole Oral Suspension (EDW Pharma, Inc. (formerly Italfarmaco Pharma, Inc.))
Oct 20, 2023
RECALLRecall (Class II): Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL), 600 mL (two bottles/300 mL each), RX only, Manufactured for …

Watch this company

Alerts for recalls, exits, and new registrations.

Facility locations, FDA inspections, and parent-company mapping are on the roadmap. Name variants reported to FDA under different spellings are merged into this profile (see “Also files as” above); figures cover the entity across all its filing names.